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U.S. Department of Health and Human Services

Safety

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Topamax (topiramate) Tablets, Sprinkle Capsules Dec 2003

Audience: Neurologists and other Healthcare professionals

Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information, notifying healthcare professionals that Topamax causes hyperchloremic, non-anion gap metabolic acidosis (decreased serum bicarbonate). Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended.

[December 2003 - Letter - Ortho-McNeil]
[December 2003 - Full, revised label- Ortho-McNeil]

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